Sep. 17, 2009 (Business Wire) -- Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ:VIVO) today announced that the company has been granted a Special 510(k) clearance to update the TRU FLU package insert to include analytical sensitivity claims with two strains of 2009 H1N1 virus cultured from positive respiratory specimens. TRU FLU is a rapid test which identifies influenza A and B in human specimens.
Meridian’s TRU FLU and TRU RSV® products are unique in that they feature a closed test system that allows a specimen to be contained within the device once it has been inserted. While the performance characteristics of the device with clinical specimens that are positive for the 2009 H1N1 influenza virus have not been established, the analytical sensitivity claims with the two strains adds an additional important product benefit.
John A. Kraeutler, Chief Executive Officer, commented, “Meridian is working diligently to provide our global customers who are facing an influenza pandemic with product features that will assist them from a testing standpoint. We must provide our customers with tools that allow them to do their jobs in a rapid, safe and effective manner, thus improving patient care.”
Meridian is a fully integrated life science company that manufactures, markets and distributes a broad range of innovative diagnostic test kits, purified reagents and related products and offers biopharmaceutical enabling technologies. Utilizing a variety of methods, these products and diagnostic tests provide accuracy, simplicity and speed in the early diagnosis and treatment of common medical conditions, such as gastrointestinal, viral and respiratory infections. Meridian’s diagnostic products are used outside of the human body and require little or no special equipment. The Company's products are designed to enhance patient well-being while reducing the total outcome costs of healthcare. Meridian has strong market positions in the areas of gastrointestinal and upper respiratory infections, serology, parasitology and fungal disease diagnosis. In addition, Meridian is a supplier of rare reagents, specialty biologicals and related technologies used by biopharmaceutical companies engaged in research for new drugs and vaccines. The Company markets its products and technologies to hospitals, reference laboratories, research centers, veterinary testing centers, physician offices, diagnostics manufacturers and biotech companies in more than 60 countries around the world. The Company’s shares are traded through NASDAQ’s Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
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